Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Phase 4

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: Ropivacaine; Drug: morphine

• Registration Number: NCT01234272
• Lead Sponsor: Yonsei University

Brief Summary

The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-03
• Study First Posted: 2010-11-04
• Primary Completion: 2011-01
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-15
• Last Update Posted: 2011-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• I or II of preoperative physical status classification by the American Society of Anesthesiologists.
• more than 20 years old.
• undergoing gastrectomy due to gastric cancer.

Exclusion Criteria

• contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly.
• prior history of abdominal surgery or spine surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCEA	Ropivacaine	PCEA:epidural PCA(patient controlled analgesia)
ITM-IVPCA	morphine	ITM-IVPCA:intrathecal morphine and IV-fentanyl patient controlled analgesia

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of